Comparison of Plasma Concentration Changes Between Two Types of Tablets of FK949E Administration to Patients With Major Depressive Disorder

NCT ID: NCT01919008

Last Updated: 2024-10-31

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 16 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-03-26
• Study Completion Date: 2012-06-22

Brief Summary

This study is to compare the pharmacokinetics of FK949E low dose tablets and FK949E high dose tablets in non-elderly patients with major depressive disorder. The safety of FK949E in the population was also evaluated.

Detailed Description

The objective of the study is to compare the pharmacokinetics of FK949E low dose tablets and FK949E high dose tablets in non-elderly patients with major depressive disorder in a 2 × 2 crossover design. The safety of FK949E in the population is also evaluated.

Conditions

Major Depressive Disorder

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Group 1 (FK949E low dose tablet-first group)

Days 1 and 2: One FK949E low dose tablet

Days 3 to 6: Three FK949E low dose tablets

Days 7 to 10: One FK949E high dose tablet

Group Type: EXPERIMENTAL

FK949E

Intervention Type: DRUG

Oral

Group 2 (FK949E high dose tablet-first group)

Days 1 and 2: One FK949E low dose tablet

Days 3 to 6: One FK949E high dose tablet

Days 7 to 10: Three FK949E low dose tablets

Group Type: EXPERIMENTAL

FK949E

Intervention Type: DRUG

Oral

Interventions

FK949E

Oral

Intervention Type: DRUG

Other Intervention Names

extended release formulation of quetiapine

Eligibility Criteria

Inclusion Criteria

• Patients considered to be able to understand and follow subject requirements, as judged by the investigator/sub-investigator.
• Patients diagnosed with major depressive disorder according to the DSM-IV-TR by means of M.I.N.I.
• BMI: 17.6 (inclusive) to 26.4 (exclusive).

Exclusion Criteria

• Current or past history of DSM-IV-TR Axis I disorder, except major depressive disorder, within the past 6 months before informed consent.
• Concurrent DSM-IV-TR Axis II disorder that is considered to greatly affect patient's current mental status.
• Current or past history of dependence of substances (other than caffeine and nicotine) or history of abuse or dependence of alcohol.
• Unable to suspend treatment with inducers or inhibitors of the drug-metabolizing enzyme, cytochrome P450 3A4 (CYP3A4), for 14 days before the screening assessment and throughout the study.
• Patients who could not use an appropriate contraception (condoms) during the study. Patients who were pregnant or lactating.
• Patients (carriers) with documented or suspected renal failure, hepatic failure, serious cardiac disease,

hepatitis B, hepatitis C, or acquired immunodeficiency syndrome (AIDS).

• Patients receiving treatment for hypertension, or patients with concurrent hypertension or unstable angina that may worsen with the study or may affect the study results based on the clinical judgment of the investigator/sub-investigator.
• Patients with concurrent hypotension (criterion for hypotension: a systolic blood pressure of less than 100 mmHg), or orthostatic hypotension
• Patients with a mean QTcF interval of ≥450 ms on a 12-lead ECG at the screening assessment
• Patients with the risk of torsades de pointe (e.g., those with a history of QT prolongation, those with familial long QT syndrome).
• Concurrent malabsorption syndrome, hepatic disease, or other conditions that may affect the absorption and/or metabolism of the study drug.
• Concurrent malignancy or history of cured malignancy within 5 years
• Current or past history of cerebrovascular disease or transient ischemic attack (TIA).
• Received electroconvulsive therapy within 90 days before the screening assessment

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 64 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Astellas Pharma Inc

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Medical Director

Role: STUDY_DIRECTOR

Astellas Pharma Inc

Locations

Kanto, , Japan

Countries

Japan

References

Fukushi R, Nomura Y, Katashima M, Komatsu K, Sato Y, Takada A. Approach to Evaluating QT Prolongation of Quetiapine Fumarate in Late Stage of Clinical Development Using Concentration-QTc Modeling and Simulation in Japanese Patients With Bipolar Disorder. Clin Ther. 2020 Aug;42(8):1483-1493.e1. doi: 10.1016/j.clinthera.2020.06.002. Epub 2020 Aug 11.

Reference Type: DERIVED

PMID: 32792252 (View on PubMed)

Related Links

https://www.astellasclinicalstudyresults.com/hcp/study.aspx?ID=175

Link to results on Astellas Clinical Study Results website

Other Identifiers

6949-CL-0006

Identifier Type: -

Identifier Source: org_study_id